Disposable Monopolar Laparoscopic Shafts and Reusable Handles
K-Number: K210569 · 2021-08-16
Device Summary
Frequently Asked Questions
What is the Disposable Monopolar Laparoscopic Shafts and Reusable Handles?
Disposable Monopolar Laparoscopic Shafts and Reusable Handles is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Dannik, LLC. The 510(k) number is K210569.
When did Disposable Monopolar Laparoscopic Shafts and Reusable Handles receive FDA 510(k) clearance?
Disposable Monopolar Laparoscopic Shafts and Reusable Handles received FDA 510(k) clearance on 2021-08-16, under 510(k) number K210569.
Who is the listed applicant for Disposable Monopolar Laparoscopic Shafts and Reusable Handles?
The FDA 510(k) record lists Dannik, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Monopolar Laparoscopic Shafts and Reusable Handles?
The FDA product code for Disposable Monopolar Laparoscopic Shafts and Reusable Handles is GEI.
Other records listing Dannik, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GEI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.